Cuvposa is a drug owned by Merz Pharmaceuticals Llc. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 20, 2023. Details of Cuvposa's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7638552 | Method for increasing the bioavailability of glycopyrrolate |
Aug, 2023
(1 year, 3 months ago) |
Expired
|
| US7816396 | Method for increasing the bioavailability of glycopyrrolate |
Aug, 2023
(1 year, 3 months ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Cuvposa's patents.
Latest Legal Activities on Cuvposa's Patents
Given below is the list of recent legal activities going on the following patents of Cuvposa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Apr, 2022 | US7816396 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 16 Jun, 2021 | US7638552 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 Apr, 2018 | US7816396 |
| Email Notification Critical | 07 Dec, 2012 | US7816396 |
| Change in Power of Attorney (May Include Associate POA) Critical | 07 Dec, 2012 | US7816396 |
| Email Notification Critical | 07 Dec, 2012 | US7638552 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) Critical | 07 Dec, 2012 | US7638552 (Litigated) |
| Correspondence Address Change Critical | 21 Nov, 2012 | US7816396 |
| Correspondence Address Change Critical | 21 Nov, 2012 | US7638552 (Litigated) |
| Email Notification Critical | 30 Aug, 2011 | US7638552 (Litigated) |
FDA has granted several exclusivities to Cuvposa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Cuvposa, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Cuvposa.
Exclusivity Information
Cuvposa holds 2 exclusivities. All of its exclusivities have expired in 2017. Details of Cuvposa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jul 28, 2013 |
| Orphan Drug Exclusivity(ODE) | Jul 28, 2017 |
US patents provide insights into the exclusivity only within the United States, but Cuvposa is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Cuvposa's family patents as well as insights into ongoing legal events on those patents.
Cuvposa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Cuvposa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 20, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cuvposa Generic API suppliers:
Glycopyrrolate is the generic name for the brand Cuvposa. 44 different companies have already filed for the generic of Cuvposa, with Watson Labs having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Cuvposa's generic
How can I launch a generic of Cuvposa before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Cuvposa's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Cuvposa's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Cuvposa -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg/5 mL | 20 Jun, 2012 | 1 | 09 Aug, 2021 | 20 Aug, 2023 | Eligible |
Alternative Brands for Cuvposa
Cuvposa which is used for reducing chronic severe drooling in patients with neurologic conditions., has several other brand drugs using the same active ingredient (Glycopyrrolate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Astrazeneca |
| ||
| Astrazeneca Ab |
| ||
| Azurity |
| ||
| Casper Pharma Llc |
| ||
| Novartis |
| ||
| Sumitomo Pharma Am |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Glycopyrrolate, Cuvposa's active ingredient. Check the complete list of approved generic manufacturers for Cuvposa
About Cuvposa
Cuvposa is a drug owned by Merz Pharmaceuticals Llc. It is used for reducing chronic severe drooling in patients with neurologic conditions. Cuvposa uses Glycopyrrolate as an active ingredient. Cuvposa was launched by Merz Pharms in 2010.
Approval Date:
Cuvposa was approved by FDA for market use on 28 July, 2010.
Active Ingredient:
Cuvposa uses Glycopyrrolate as the active ingredient. Check out other Drugs and Companies using Glycopyrrolate ingredient
Treatment:
Cuvposa is used for reducing chronic severe drooling in patients with neurologic conditions.
Dosage:
Cuvposa is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1MG/5ML | SOLUTION | Prescription | ORAL |